Dental anestesi applisert som nesespray godkjent av FDA

0
31

Juli 2016 godkjente FDA legemidlet KOVANAZE for anestesi av overkjens tenner: 15 til 25 hos voksne og 55 til 65 hos barn, uten anestesisprøyte og nålestikk.

Relevante linker: FDA  og  ADA

Utdrag fra PRESS RELEASE (på denne linken):
(OBS at nomenklatur for tenner i USA er forskjellig fra Europa)

kovanze 200x72St. Renatus, LLC Announces FDA Approval of KOVANAZE (tetracaine HCl and oxymetazoline HCl) Nasal Spray for Use in Dentistry

 

July 12, 2016 – St. Renatus LLC, a privately held company based in Fort Collins, Colorado, is pleased to announce it received U.S. Food and Drug Administration (FDA) approval on June 29, 2016 for its first product, a new dental anesthetic, KOVANAZE  (tetracaine HCl and oxymetazoline HCl) Nasal Spray.

This is the first product that allows for dental anesthesia to be administered through a nasal spray without using a needle.

“For more than 100 years, the dental industry has delivered dental anesthesia using a needle injection. Now, through the efforts of a dedicated team, we have developed a revolutionary needle-free method for delivering pulpal anesthesia,” said Steve Merrick, St. Renatus’ CEO.

Kovanaze is intended for use in dentistry as a topical anesthetic, delivered in the nasal cavity to achieve pulpal (tooth nerve) anesthesia for the restorative treatment of teeth. Like traditional dental injections, this product delivers a local dental anesthetic but without the needle.

Kovanaze is in20160727-teeth-chartdicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

About St. Renatus:
St. Renatus, LLC was founded to develop a revolutionary innovation—the world’s first-known dental anesthetic administered through the nasal cavity, designed for use in procedures involving most of the upper teeth, with a goal of gaining FDA approval to commercialize and distribute. The company’s name comes from the patron saint of anesthesia and has Latin roots meaning new beginning.

Contact: Jennifer Umland, Media Relations
970-282-0156 ext. 3517 – jumland@st-renatus.com